Cytokinetics Announces Presentation of Additional Results From COSMIC-HF at the HFSA 21st Annual Scientific Meeting
September 18 2017 - 7:30AM
Cytokinetics, Incorporated (Nasdaq:CYTK) today announced that
additional results from COSMIC-HF (
Chronic
Oral
Study of
Myosin Activation to
Increase
Contractility in
Heart
Failure), a Phase 2 trial evaluating omecamtiv
mecarbil in patients with chronic heart failure, were presented in
a Rapid Fire Abstracts Presentation at the 21st Annual Heart
Failure Society of America Scientific Meeting in Dallas, Texas. The
results, presented by John Teerlink, M.D., Professor of Clinical
Medicine at the University of California San Francisco and Director
of Heart Failure at the San Francisco Veterans Affairs Medical
Centers, suggest that omecamtiv mecarbil may produce similar
results with regard to cardiac function, heart rate, biomarkers and
adverse events in patients with ischemic and non-ischemic etiology
of heart failure. Omecamtiv mecarbil, a novel investigational
cardiac myosin activator that increases cardiac contractility, is
being developed by Amgen in collaboration with Cytokinetics for the
potential treatment of heart failure.
“We are pleased to see that the effects of
omecamtiv mecarbil in patients with heart failure appeared similar
regardless of disease etiology in COSMIC-HF,” said Fady I. Malik,
MD, PhD, Cytokinetics' Executive Vice President, Research and
Development. “In GALACTIC-HF, we look forward to learning if these
effects may translate into meaningful improvement in clinical
outcomes in patients with heart failure.”
COSMIC-HF: Expansion Phase Design and
Results
The expansion phase of COSMIC-HF evaluated the
pharmacokinetics, pharmacodynamics, safety and tolerability of oral
omecamtiv mecarbil in 448 patients with chronic heart failure and
left ventricular systolic dysfunction. Patients were randomized
1:1:1 to receive either placebo or treatment with omecamtiv
mecarbil dosed as 25 mg twice daily or 25 mg twice daily with dose
escalation to 50 mg twice daily, depending on a plasma
concentration of omecamtiv mecarbil after two weeks of treatment.
Results of COSMIC-HF, published in The Lancet, showed that the
clinical trial met its primary pharmacokinetic objective and showed
statistically significant improvements in all pre-specified
secondary measures of cardiac function in the treatment group
receiving pharmacokinetic-based (PK) dose titration.
Recent secondary analyses of data from COSMIC-HF
evaluated the effects of omecamtiv mecarbil in patients with
ischemic heart failure and those with non-ischemic heart failure,
64 percent and 36 percent of the trial population,
respectively. The analyses suggest that omecamtiv
mecarbil produced similar findings with regard to its
pharmacodynamic response including cardiac function and ventricular
size, heart rate, and NT-proBNP in patients with both ischemic and
non-ischemic etiologies of heart failure. There was no
difference in the mean change from baseline in troponin after 20
weeks of therapy between the ischemic and non-ischemic PK-dose
titration groups that received omecamtiv mecarbil. Overall and
cardiac adverse events were similar between the placebo and PK-dose
titration groups for patients with ischemic and non-ischemic
etiologies. Further studies are needed to confirm these preliminary
findings.
About Omecamtiv Mecarbil
Omecamtiv mecarbil is a novel cardiac myosin
activator. Cardiac myosin is the cytoskeletal motor protein in the
cardiac muscle cell that is directly responsible for converting
chemical energy into the mechanical force resulting in cardiac
contraction. Cardiac myosin activators are thought to accelerate
the rate-limiting step of the myosin enzymatic cycle and shift the
enzymatic cycle in favor of the force-producing state. Preclinical
research has shown that cardiac myosin activators increase
contractility in the absence of changes in intracellular calcium in
cardiac myocytes. Omecamtiv mecarbil is being developed by Amgen in
collaboration with Cytokinetics. Amgen holds an exclusive,
worldwide license to omecamtiv mecarbil and related compounds,
subject to Cytokinetics’ specified development and
commercialization rights. Amgen has also entered an alliance with
Servier for exclusive commercialization rights in Europe as well as
the Commonwealth of Independent States, including Russia. Servier
contributes funding for development and provides strategic support
to the program.
About Cytokinetics
Cytokinetics is a late-stage biopharmaceutical
company focused on discovering, developing and commercializing
first-in-class muscle activators as potential treatments for
debilitating diseases in which muscle performance is compromised
and/or declining. As a leader in muscle biology and the mechanics
of muscle performance, the company is developing small molecule
drug candidates specifically engineered to increase muscle function
and contractility. Cytokinetics’ lead drug candidate is tirasemtiv,
a fast skeletal muscle troponin activator (FSTA). Tirasemtiv is the
subject of VITALITY-ALS, an international Phase 3 clinical trial in
patients with ALS. Tirasemtiv has been granted orphan drug
designation and fast track status by the U.S. Food and Drug
Administration (FDA) and orphan medicinal product designation by
the European Medicines Agency for the potential treatment of ALS.
Cytokinetics is preparing for the potential commercialization of
tirasemtiv in North America and Europe and has granted an option to
Astellas Pharma Inc. (“Astellas”) for development and
commercialization in other countries. Cytokinetics is collaborating
with Astellas to develop CK-2127107, a next-generation FSTA.
CK-2127107 has been granted orphan drug designation by the FDA for
the potential treatment of SMA. CK-2127107 is the subject of three
ongoing Phase 2 clinical trials enrolling patients with spinal
muscular atrophy, chronic obstructive pulmonary disease and ALS.
Astellas is also conducting a Phase 1b clinical trial of CK-2127107
in elderly adults with limited mobility. Cytokinetics is
collaborating with Amgen Inc. (“Amgen”) to develop omecamtiv
mecarbil, a novel cardiac muscle activator. Omecamtiv mecarbil is
the subject of GALACTIC-HF, an international Phase 3 clinical trial
in patients with heart failure. Amgen holds an exclusive worldwide
license to develop and commercialize omecamtiv mecarbil with a
sublicense held by Servier for commercialization in Europe and
certain other countries. Astellas holds an exclusive worldwide
license to develop and commercialize CK-2127107. Licenses held by
Amgen and Astellas are subject to Cytokinetics' specified
co-development and co-commercialization rights. For additional
information about Cytokinetics, visit
http://www.cytokinetics.com/.
Forward-Looking Statements
This press release contains forward-looking
statements for purposes of the Private Securities Litigation Reform
Act of 1995 (the “Act”). Cytokinetics disclaims any intent or
obligation to update these forward-looking statements, and claims
the protection of the Act’s Safe Harbor for forward-looking
statements. Examples of such statements include, but are not
limited to, the properties and potential benefits of Cytokinetics’
drug candidates, including omecamtiv mecarbil; the design, timing,
results and significance of the Phase 3 clinical trial of omecamtiv
mecarbil in subjects with chronic heart failure and reduced
ejection fraction in GALACTIC-HF; and the potential for eventual
regulatory approval, commercialization and launch of Cytokinetics’
product candidates. Such statements are based on management's
current expectations, but actual results may differ materially due
to various risks and uncertainties, including, but not limited to
Amgen's decisions with respect to the design, initiation, conduct,
timing and continuation of development activities for omecamtiv
mecarbil; potential difficulties or delays in the development,
testing, regulatory approvals for trial commencement, progression
or product sale or manufacturing, or production of Cytokinetics'
drug candidates that could slow or prevent clinical development or
product approval, including risks that current and past results of
clinical trials or preclinical studies may not be indicative of
future clinical trials results, patient enrollment for or conduct
of clinical trials may be difficult or delayed, Cytokinetics' drug
candidates may have adverse side effects or inadequate therapeutic
efficacy, the U.S. Food and Drug Administration or foreign
regulatory agencies may delay or limit Cytokinetics' or its
partners' ability to conduct clinical trials; Cytokinetics may be
unable to obtain or maintain patent or trade secret protection for
its intellectual property; Cytokinetics may incur unanticipated
research and development and other costs or be unable to obtain
additional financing necessary to conduct development of its
products; standards of care may change, rendering Cytokinetics'
drug candidates obsolete; and competitive products or alternative
therapies may be developed by others for the treatment of
indications Cytokinetics' drug candidates and potential drug
candidates may target. For further information regarding these and
other risks related to Cytokinetics' business, investors should
consult Cytokinetics' filings with the Securities and Exchange
Commission. Forward-looking statements are not guarantees of future
performance, and Cytokinetics' actual results of operations,
financial condition and liquidity, and the development of the
industry in which it operates, may differ materially from the
forward-looking statements contained in this press release. Any
forward-looking statements that Cytokinetics makes in this press
release speak only as of the date of this press release.
Contact:CytokineticsDiane
WeiserVice President, Corporate Communications, Investor
Relations(415) 290-7757
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